The MICRO2+ is intended for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate during both no motion and motion conditions, and for patients who are well or poorly perfused, using a range of compatible sensors. The device will produce visual and aural alarms if these parameters vary beyond preset limits.

The MICRO2+ is indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate during both no motion and motion conditions, and for patients who are well or poorly perfused.

Device Description

The release of software version VA1 includes a re-labeling of the MicrO2+ and the recognition of Nellcor OxiMax sensors. The modifications implemented with the release of software version VA1 have not altered the basic fundamental technology of the MicrO2+.

AI/ML Overview

The provided text is a 510(k) summary for the Siemens MicrO2+ with VA1 Software. This document focuses on a Special 510(k) Notification for modifications to an already legally marketed device (MICRO2+, 510(k) K012770). Special 510(k)s typically involve modifications to a manufacturer's own legally marketed device where the modification does not alter the fundamental technology or intended use.

Therefore, the submission primarily demonstrates that the modifications (re-labeling and recognition of Nellcor OxiMax sensors, and updated software) do not raise new questions of safety and efficacy compared to the predicate device. It does not present a detailed study proving the device meets acceptance criteria as would be found in an original 510(k) submission for a new device, or a comprehensive de novo submission.

Information regarding detailed performance studies, specific acceptance criteria values, sample sizes for test and training sets, expert qualifications, and ground truth establishment, as requested in the prompt, are not present in this Special 510(k) summary. These types of detailed performance data would have been part of the original 510(k) for the predicate device (K012770) or would be available in the full submission, not just the summary.

Based on the provided text, I cannot complete most of the requested information because the document is a Special 510(k) focused on modifications to an existing device rather than a comprehensive performance study for a new device.

However, I can extract what limited information is available and explain why other details are missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in this document. For oximeters, acceptance criteria typically involve accuracy (bias and precision) against a reference standard over a range of SaO2 values and under various conditions (motion, low perfusion). This information would have been part of the predicate device's cleared 510(k).
Reported Device Performance: The document states:
- "Testing with VA1 software indicates no new issues relative to safety and efficacy."
- This implies that the modified device's performance is considered equivalent to the predicate device, which presumably met certain acceptance criteria. However, specific performance metrics for the VA1 software itself are not detailed here.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not specified in this document.
Data Provenance: Not specified in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not applicable/not specified. The document does not describe the establishment of a ground truth for a test set in the context of human interpretation or expert review, as this is a pulse oximeter.
Qualifications of Experts: Not applicable/not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/not specified. This type of adjudication is typically for image-based diagnostic devices where expert consensus is needed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a pulse oximeter, not an AI-assisted diagnostic imaging device that involves human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device (Siemens MicrO2+) is an oximeter, which inherently functions as a "standalone" algorithm device in that it directly measures and displays physiological parameters. The "algorithm" here refers to the processing of sensor data to derive SpO2 and pulse rate. The document doesn't detail performance studies specific to the VA1 software beyond stating "no new issues relative to safety and efficacy." The original 510(k) for the predicate device would have included the standalone performance of its oximetry algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For pulse oximeters, the ground truth is typically established using arterial blood gas analysis (co-oximetry), which is considered the gold standard for measuring arterial oxygen saturation (SaO2). The original performance studies for the predicate device would have compared the device's SpO2 readings to SaO2 values obtained from co-oximetry. This information is not present in the provided document.

8. The sample size for the training set:

Not applicable/not specified. The document describes modifications to an existing device, not the development of a new algorithm where training set sizes are typically reported.

9. How the ground truth for the training set was established:

Not applicable/not specified.

Summary of what can be gleaned from the text:

Device: Siemens MicrO2+ with VA1 Software (Modified Pulse Oximeter).
Key Modification: Re-labeling and recognition of Nellcor OxiMax sensors, and updated software.
Regulatory Path: Special 510(k) Notification, meaning the submission focused on demonstrating that the modifications did not alter the basic fundamental technology or raise new issues of safety and efficacy compared to the predicate device (K012770).
Performance Statement: "Testing with VA1 software indicates no new issues relative to safety and efficacy." This implies the modified device performed equivalently to the predicate device, which previously met its performance requirements.
Intended Use: Continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate during both no motion and motion conditions, for well or poorly perfused patients.

The provided text is a high-level summary for a specific type of regulatory submission (Special 510(k)) and is not designed to contain the detailed technical validation data requested.

Summary

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K030640

Special 510(k) Notification SIEMENS MicrO2+ VA1 Modifications

510(k) SUMMARY

as required per 807.92(c)

Submitters Name, Address:

Siemens Medical Solutions USA, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879 Official Correspondent: Connie Hertel, Director Quality Assurance & Regulatory Affairs Contact person for this submission: Penelope H. Greco Date submission was prepared: February 26, 2003

Trade Name, Common Name and Classification Name:

A. Trade Name: Siemens MicrO2+ Nellcor N-45
B. Common Name, Classification Name, Class and Regulation Number:

Common Name	Product Code	Class	Regulation Number
Oximeter	74 DQA	II	870.2700
Ear Oximeter	74 DPZ	II	870.2710

Legally Marketed Device Identification: MICRO2+, 510(k) K012770

Description of Modification:

16 Electronics Avenue Danvers, MA 01923

Tel: (978) 907-7500 Fax: (978) 750-6879

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Intended Use:

Assessment of non-clinical performance data for equivalence: See Section J

Assessment of clinical performance data for equivalence: See Section J

Biocompatability: Not applicable

Sterilization: Not applicable

Standards and Guidances: See Section J

Page 2 of 2

16 Electronics Avenue Danvers, MA 01923

Tel: (978) 907-7500 Fax: (978) 750-6879

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 3 2003

Ms. Penelope H. Greco Siemens Medical Solutions USA, Inc. Electromedical Systems Group, PCS 16 Electronics Avenue Danvers, MA 01923

Re: K030640

Trade/Device Name: Siemens MicrO2+ with VA1 Software Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: May 23, 2003 Received: May 27, 2003

Dear Ms. Greco:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 – Ms. Penelope H. Greco

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Susan Rumm

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1 --

510(k) Number (if known): KC 306 YO

Device Name: Siemens INFINITY MICRO2+

Indications for Use:

MRI Compatibility Statement: The Siemens INFINITY MICRO2+ is not intended for use in a MRI magnetic field.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use____________

(Optional Format 1-2-96)

Susan Pearson

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: 4/3k3

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).